Medical Device | December 23, 2021
U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath
Philips’s CavaClear is intended to safely ablate tissue to remove embedded IVC filters
Philips’s CavaClear is intended to safely ablate tissue to remove embedded IVC filters
Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
Immatics to receive upfront payment of US $ 150 million and additional milestone payments of up to US $ 770 million plus tiered double-digit royalties on net product sales
The combination rapid antigen test quickly differentiates between SARS-CoV-2 and influenza viruses A and B infections, with results ready in less than 30 minutes, allowing informed decisions on patient and pandemic management decisions
Market demand for significant volumes and quality of biopharma products would drive continuous manufacturing technologies
Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults
Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline
Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for the millions of Americans living with diabetes
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